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Life Threatening? No
Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 94 year old male and unspecified race & ethinicity. Initial information was processed along with the additional information received on 27-AUG-2021 The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes, hypertension, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 in total dose was administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The consumer reported that father was in the emergency room on 17-AUG-2021 and was hospitalized. On 18-AUG-2021, the patient was on ventilator and died on 24-AUG-2021 with the delta variant. On an unspecified date, the patient had suspected covid-19 infection, and suspected clinical vaccination failure. On 24-AUG-2021, the patient died from covid-19 infection. The patient was hospitalized for 7 days. It was unspecified if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 infection on 24-AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210858457-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210858457-covid-19 vaccine ad26.cov2.s- suspected covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COVID-19 INFECTION
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